FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
19393–19416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 2020
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
K201112 · DSP
Arrow International, Inc.
Cardiovascular · 30d
Cleared May 27, 2020
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K201120 · NFT
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 30d
Cleared May 26, 2020
High-speed air turbine handpiece / Low-speed air turbine handpiece
K181691 · EFB
Foshan Wenjian Medical Instrument...
Dental · 699d
Cleared May 26, 2020
DiaPlus
K192392 · KLE
DiaDent Group International
Dental · 266d
Cleared May 26, 2020
Aqua Naina Sterile Saline Solution
K193441 · LPN
Chemtex USA, Inc.
Ophthalmic · 167d
Cleared May 26, 2020
The iNAP One Sleep Therapy System
K193460 · OZR
Somnice, Inc.
Anesthesiology · 162d
Cleared May 26, 2020
ReWalk P6.0
K200032 · PHL
Re Walk Robotics , Ltd.
Neurology · 140d
Cleared May 26, 2020
NPseal
K200305 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 110d
Cleared May 26, 2020
UNIEXPERT 2 PLUS
K200944 · KPR
Adani
Radiology · 48d
Cleared May 26, 2020
Maximus System
K200988 · NHJ
Hill-Rom Services Pte, Ltd.
Anesthesiology · 41d
Cleared May 26, 2020
GentleMax Pro Plus
K201111 · GEX
Candela Corporation
General & Plastic Surgery · 29d
Cleared May 26, 2020
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level,...
K201118 · GWM
Medtronic, Inc.
Neurology · 29d
Cleared May 26, 2020
ACUSON Juniper Diagnostic Ultrasound System
K201130 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 22, 2020
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559 · LJT
AngioDynamics, Inc.
General Hospital · 444d
Cleared May 22, 2020
Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use...
K191847 · GEI
Adeor Medical AG
General & Plastic Surgery · 317d
Cleared May 22, 2020
CO2 Sidestream Module
K192488 · CCK
Beijing Kingst Commercial & Trade...
Anesthesiology · 254d
Cleared May 22, 2020
Surgical Gown
K192560 · FYA
Shandong Kangli Medical Equipment...
General Hospital · 248d
Cleared May 22, 2020
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
K193423 · NKB
Icotec AG
Orthopedic · 165d
Cleared May 22, 2020
VERIFY Assert Self-Contained Biological Indicator
K200126 · FRC
STERIS Corporation
General Hospital · 122d
Cleared May 22, 2020
JPS JuniOrtho Plating System
K200246 · HRS
Orthofix Srl
Orthopedic · 112d
Cleared May 22, 2020
Reconnaissance PV .018 OTW Digital IVUS Catheter
K200410 · OBJ
Philips Image Guided Therapy Corporation
Cardiovascular · 93d
Cleared May 22, 2020
Kalera Vacuum Aspiration Catheter (K-VAC)
K200419 · FED
Kalera Medical, Inc.
Gastroenterology & Urology · 92d
Cleared May 22, 2020
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant,...
K200457 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 87d
Cleared May 22, 2020
Invictus™ CT Spinal Fixation System
K200936 · NKG
Alphatec Spine, Inc.
Orthopedic · 44d